Indiana Code
Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers
25-26-14-17.2. For Cause Authentication

Sec. 17.2. (a) A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor and has reason to believe that a legend drug purchased from the other wholesale drug distributor is counterfeit, suspected counterfeit, misbranded, or adulterated shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.
(b) A wholesale drug distributor that has engaged in the distribution of a legend drug for which a purchasing wholesale drug distributor conducts a for cause authentication under subsection (a) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone number, and electronic mail address of the wholesale drug distributor that sold the legend drug.
(c) If a wholesale drug distributor conducts a for cause authentication under subsection (a) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration, if applicable, not more than ten (10) business days after completing the attempted authentication.
(d) If a wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (a), the wholesale drug distributor shall maintain records of the authentication for three (3) years and shall produce the records for the board and the federal Food and Drug Administration upon request.
As added by P.L.212-2005, SEC.54. Amended by P.L.98-2006, SEC.21.

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